{"publicDeviceRecordKey":"c52555f3-4005-40b4-8516-5ded050a01d9","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2019-10-23T00:00:00.000Z","devicePublishDate":"2017-08-21T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10853879007338","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00853879007331","pkgQuantity":4,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Case Pack"},{"deviceId":"00853879007331","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Beurer","versionModelNumber":"EM34","catalogNumber":null,"dunsNumber":"078497467","companyName":"BEURER NORTH AMERICA, L.P.","deviceCount":1,"deviceDescription":"Tens Device Knee / Elbow 2 in 1\nFor the temporary relief of pain associated with sore and aching muscles ","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":true,"contacts":{"customerContact":[{"phone":"1-800-536-0366","phoneExtension":null,"email":"info@beurer.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35372","gmdnPTName":"Analgesic transcutaneous electrical nerve stimulation system","gmdnPTDefinition":"An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NUH","productCodeName":"Stimulator, Nerve, Transcutaneous, Over-The-Counter"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}